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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K924142
Device Name CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT
Applicant
Codman & Shurtleff, Inc.
C/O Burckman Co., Inc.
1000 Burnett Ave., Suite 250
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Codman & Shurtleff, Inc.
C/O Burckman Co., Inc.
1000 Burnett Ave., Suite 250
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3050
Classification Product Code
KWP  
Date Received08/17/1992
Decision Date 06/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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